AT-Closed Vial®
CONCEPT MATERIALS
The AT-Closed Vial® Technology is based Materials selected for the product contact on the concept of the ready-to-fill Closed Vial, parts meet USP and EP requirements for whereby polymer vials are provided: pharmaceutical primary container:
clean (molded in ISO5 clean room); COC (Cyclo-Olefin Co-polymer) for vial body; already closed (stopper in place and secured); TPE (Thermo Plastic Elastomer) for stopper. sterilized (gamma-irradiated).
FIELDS OF USE
Biological Potent Cryostored
Vaccines Cytotoxics Cell therapy
V3.0
mAbs Radiopharmaceuticals Gene therapy – RNA/DNA-based products Nanomedicines Other low T° storage products
Low leachable profile, twice Unbreakable container, always Container Closure Integrity even in less particles then in glass vial closed to avoid contamination liquid nitrogen
BrochureCrystal Vials&Lines
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AT-Closed Vial® 1 ml 2 ml 6 ml 10 ml 20 ml 50 ml Height (in mm, +1mm if capped) 33.10 33.10 39.30 49.80 61.20 84.90
External vial diameter (in mm) 18.30 22.30 25.00 25.00 30.00 36.00
AsepticTechnologies
– Maximum volume filled (in ml) 1.35 2.25 7.60 11.70 21.80 52.10
Cryogenic storage can be cryopreserved while keeping Container Closure Integrity
© 2016 © Colored caps are available in different colors for product differentiation
Specific solutions for UV-, O2-sensitive, lyophilized products can be offered.
Crystal Filling Lines
PROCESS SCALING-UP
The overall filling process of the ready-to-fill Straightforward scaling-up: identical ® AT-Closed Vials is made of very few steps: processing, tools and disposables are used at 1. Filling: the stopper is pierced by a all capacity levels. specially designed needle dispensing the product inside the container; VALIDATION 2. Closing: the puncture trace is re-sealed by a laser shot on the stopper; To support the approval of your products, 3. Capping: simple snap-fit of plastic cap, complete Validation Master Plan (VMP) is ® inside the barrier. provided with every Crystal Filling Line.
Ready-to-fill AT-Closed Vial® 3 process steps: filling, laser re-sealing, capping Filled AT-Closed Vial®
Crystal® M1 Crystal® L1 Crystal® SL1 Crystal® PX
Filling Station Robot Line Robot Line Filling Line AT-Closed Vial®, Container AT-Closed Vial® AT-Closed Vial® Prefilled Syringe, AT-Closed Vial® ( ) Open Glass Vial 1 Max. output 180 u/h 600 u/h 600-700 u/h 6.000-10.800 u/h BSC RABS RABS RABS Containment or Isolator or Isolator or Isolator or Isolator 1 m2 1,5 m2 1,5 m2 12-18 m2 Typical footprint 11 ft2 16 ft2 16 ft2 130-195 ft2 Closing IPC 100% 100% 100% 100% Utilities WFI: - - - - Vacuum: - - Yes - Electricity: Yes Yes Yes Yes
More information available on www.aseptictech.com Aseptic Technologies S.A. reserves the right to make any changes to the described equipment and characteristics without notice.
(1) Ready-to-fill nested containers.